Rotational Thromboelastometry for the Transfusion Management of Postpartum Hemorrhage After Vaginal or Cesarean Delivery

Postpartum Hemorrhage Clinical Trial

Official title:

Rotational Thromboelastometry for the Transfusion Management of Postpartum Hemorrhage After Vaginal or Cesarean Delivery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03064152
• Other study ID #: 2016P001800
• Status: Terminated
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: April 1, 2020

Study information

• Verified date: May 2021
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the impact of a rotational thromboelastometry (ROTEM®)-based transfusion protocol during postpartum hemorrhage (PPH) after vaginal or cesarean delivery. Maternal transfusion requirement, quantitative blood loss (QBL), need for intensive care unit (ICU) admission, and length of hospital stay will be evaluated. The utilization of ROTEM® for transfusion management will identify patients who develop early coagulation changes such as hypofibrinogenemia or disseminated intravascular coagulation. Our hypothesis is that earlier identification and directed therapy of such coagulation changes will lower overall transfusion requirement (packed red blood cells, fresh frozen plasma, fibrinogen concentrate, cryoprecipitate, or other product), reduce the need for ICU admission, and shorten length of hospital stay. A cost analysis will be performed.

Description:

Postpartum hemorrhage is increasing in incidence in the United States, renewing interest in targeted approaches to transfusion during cesarean delivery. ROTEM-based transfusion for PPH has been advocated as a mechanism to lower overall requirement of blood components transfused and lower the incidence of transfusion-associated pulmonary morbidity in a small study of women undergoing cesarean delivery. However, larger-scale randomized evaluation of this transfusion approach is warranted for women who experience hemorrhage after vaginal or cesarean delivery. A lower serum fibrinogen level (< 200 mg/dL) at the onset of PPH has a positive predictive value of 100% for progression to severe PPH. However, serum fibrinogen testing has a turnaround time of one hour and is therefore not useful for acute management of PPH. ROTEM provides point-of-care results that have been validated as surrogate markers for serum fibrinogen, within 10 minutes. However, whether ROTEM data alters empiric management of acute PPH is unknown. A comparison of transfusion management decisions and costs incurred for transfused products and transfusion-related morbidity (duration of hospitalization, intensive care unit, respiratory complications) will be performed.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 49
• Est. completion date: April 1, 2020
• Est. primary completion date: February 7, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) II or III health status (minimal to no systemic disease), age between 18 and 50 yrs, singleton pregnancies admitted for labor and delivery anticipated or actual PPH, or anticipated transfusion of blood products.

This will be defined by one or more of the following eligibility criteria:

1. Cesarean delivery with moderate or high risk for PPH (see below).

2. Cesarean delivery with acute PPH of > 1000 mL and blood products ordered from the blood bank.

3. Vaginal delivery with acute PPH of > 500 mL and blood products ordered from the blood bank. For criterion #1, moderate risk for PPH is defined by one or more of the following

features:

• prior cesarean delivery in labor
• prior cesarean delivery with known adhesive disease of the placenta
• multiple gestation
• >4 previous vaginal births
• chorioamnionitis with maternal temperature > 101 degrees Fahrenheit
• history of previous PPH
• large uterine fibroids (> 5 cm)
• second stage of labor (10cm cervical dilation to delivery) > 3 hours

High risk for postpartum hemorrhage is defined by one or more of the following features:

• suspected placenta accreta by pre-delivery ultrasound findings
• placenta previa (current or resolved within 4 weeks of delivery) or low-lying placenta
• active bleeding on admission prior to delivery

Exclusion Criteria:

• known coagulation defect prior to delivery including inherited (hemophilia A, von Willebrand disease, thrombocytopenia, other) or iatrogenic causes (anticoagulation therapy), refusal to accept blood transfusion (Jehovah's Witness, other).

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Device:
• Rotational Thromboelastometry
ROTEM is a point-of-care coagulation assay.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Blood Products Transfused	Total number of packed red blood cells (PRBCs), fresh frozen plasma (FFP), platelets, cryoprecipitate, cell salvage units	t0 = diagnosis of PPH by criteria defined; t final = 48h after onset of PPH.
Secondary	Blood Loss	Visual estimate in suction canister and sponges, or quantitative blood loss	From the onset of PPH through 4 hours from leaving the operating room or within 4 hours from the last blood transfusion, whichever occurs later and on average 5 hours.
Secondary	Number of Participants With Admission to the Intensive Care Unit	Need for admission to the intensive care unit after delivery	within 2 weeks of delivery
Secondary	Number of Participants Who Required a Hysterectomy	Hysterectomy to control postpartum hemorrhage.	within 2 weeks of delivery
Secondary	Number of Participants Who Experienced Maternal Mortality	Maternal death after delivery.	within 2 weeks of delivery